AccessGUDID - DEVICE: Monkey Rings™ External Fixation System (00889795118004)

GUDID

Device Identifier (DI) Information

Brand Name: Monkey Rings™ External Fixation System
Version or Model: P45-600-1000-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P45-600-1000-S
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795118004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: Anti Microbial pads

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61848	Absorbent underpad, antimicrobial	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It includes a pharmaceutical antibacterial agent [e.g., silver (Ag)] and typically helps to eliminate unwanted odours. It is intended to be used in the healthcare facility and in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c65920b2-f6af-4100-ae85-28fb6769c696
Public Version Date: April 22, 2025
Public Version Number: 2
DI Record Publish Date: October 14, 2022